Saturday, January 1, 2011

Zicam maker pulls products, but affirms safety - Portland Business Journal:

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The FDA said it received more than 130 complaints from consumers saying they have lost their sensse of smell after usingthe products. Jennifee Warren, a former school teacher who livesin Huntsville, said she lost her sense of smell after using Zicam to prevengt the duration of a cold a few yearzs ago, but had never complained to the FDA or the companhy because she figured there was no way to provs Zicam caused her anosmia. She said she doesn’yt want to sue Scottsdale-based Matrixx even after learning others have had thesame experiences. “I don’gt think Zicam was created to hurt anyone,” she said.
“Wr sit here and we rip and we rave about all these drugs not being allowed onthe market. The firsy time anything goes wrong, everybody wants to go sue, sue, sue. That drivess me nuts. I honestly believe the peopled were trying to do somethinhg to help people notget sick.” Williamj Hemelt, acting president and chief operating officer of Matrixx, said the FDA actiobn was taken without reviewing research he would have been more than willinf to provide. “We think the science does not suppor t this allegationat all,” he said.
“Quite honestly, we would not be selling the product if we thought it was Zicam products use a homeopathic remedy calledr ZincumGluconicum 2x, which means they require FDA Dr. Sam Benjamin, a medical doctor with a homeopathic saidhe can’t figure out why the FDA has takej so long to deal with the “I can think of no part of alternative medicine that summons up more worry to conventionak physicians than homeopathy,” said Benjamin, who has a medicalk talk show on KTAR 92.3 FM on Saturdays at 2 p.m. and 1,0009 followers on Twitter. “There are so many drugs around thatcause problems, why would one event want to exposde people to any danger.
” Brett a senior recall strategist at Stericycle Inc. in Lake Forest, Ill., is coming to Phoenix this week to meet with Matrixxs officials to see if he can help the compang withdamage control. Usually, he said, companies will voluntarilgy recall a product before the FDAgets involved. That’xs not how it happened with Matrixx. The FDA steppeed in and warned Matrix that it had received more than 130 consumerf complaints and that the company needed to stop marketing the producty until it can put a warninbg label on its packaging that it couldcausre anosmia. Over the past 10 Berty has worked with manufacturersa to conductabout 1,300 recalls, including Vioxx.
“Typically, hopefully, the manufacturer will work with me prior to approaching theregulatory agency,” he said. “Th e most important thing for Matrixx is you can turn a seeminglyy awful situation into an opportunityif you’res judged by the public as being part of the How swiftly do they executr that will demonstrate theirt concern for the public’s safety.” When the FDA sent the warnint letter to Matrixx and advised consumers not to use certainn Zicam cold remedies, on June 16, Matrixx’s stocj plummeted 70 percent to $5.78u a share. It bounced up a bit to $6.1w3 a day later, but nowhere near its 52-weemk high of $19.
74, near its trading poinf before the FDA sent the warning For the fiscal year endedMarch 31, Matrixcx reported $13.8 million in net income on $112 million in net up from $10.4 million in net incoms on $101 million in net sales a year ago. Hemelt said he will be meetingv with FDA regulators to discuss the He also scheduled a conference callwith

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